@article{c378de3e6bb649db8e2cb3a1c5e9b363,
title = "Sex bias in basic and preclinical noise-induced hearing loss research",
abstract = "Introduction: Sex differences in brain biochemistry, physiology, structure, and function have been gaining increasing attention in the scientific community. Males and females can have different responses to medications, diseases, and environmental variables. A small number of the approximately 7500 studies of noise-induced hearing loss (NIHL) have identified sex differences, but the mechanisms and characterization of these differences have not been thoroughly studied. The National Institutes of Health (NIH) issued a mandate in 2015 to include sex as a biological variable in all NIH-funded research beginning in January 2016. Materials and Methods: In the present study, the representation of sex as a biological variable in preclinical and basic studies of NIHL was quantified for a 5-year period from January 2011 to December 2015 prior to the implementation of the NIH mandate. Results: The analysis of 210 basic and preclinical studies showed that when sex is specified, experiments are predominantly performed on male animals. Discussion: This bias is present in studies completed in the United States and foreign institutions, and the proportion of studies using only male participants has actually increased over the 5-year period examined. Conclusion: These results underscore the need to invest resources in studying NIHL in both sexes to better understand how sex shapes the outcomes and to optimize treatment and prevention strategies.",
keywords = "Basic research, noise-induced hearing loss, preclinical research, sex bias",
author = "Lauer, {Amanda Marie} and Schrode, {Katrina Marie}",
note = "Funding Information: The question of sex-specific effects of noise exposure is most likely to be resolved by studies in animals, where noise exposure can be precisely controlled. In chinchillas exposed to loud noise, males exhibited larger threshold shifts at lower frequencies, whereas females exhibited larger threshold shifts at higher frequencies.[19,20] Other studies in mice have shown sex differences in hearing outcomes after exposure to an augmented acoustic environment (moderate level background sounds) intended to prevent hearing loss.[25,26] These few studies are just a small fraction of the approximately 8000 NIHL studies referenced in the PubMed database. In 2015, the National Institutes of Health (NIH) issued a mandate to include sex as a biological variable in all NIH-funded research beginning in January 2016. Clinical trials funded by NIH have been required to include women since 1993 when Congress passed the Revitalization Act. Sex bias has been identified in basic and preclinical surgical, neuroscience and biomedical research.[27-29] In the present study, the representation of sex as a biological variable in preclinical and basic studies of NIHL was quantified for a 5-year period from January 2011 to December 2015 to determine the representation of this variable prior to the implementation of the NIH mandate and to better understand the extent of investigation in to the sex-specific effects of noise exposure. Funding Information: This work was supported by NIH grants DC000023, DC012352, and the David M. Rubenstein Fund for Research. Publisher Copyright: {\textcopyright} 2017 Noise & Health - Published by Wolters Kluwer-Medknow.",
year = "2017",
month = sep,
day = "1",
doi = "10.4103/nah.NAH_12_17",
language = "English (US)",
volume = "19",
pages = "207--212",
journal = "Noise and Health",
issn = "1463-1741",
publisher = "Medknow Publications and Media Pvt. Ltd",
number = "90",
}